• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Electromagnetic Interference (1194); Unintended Collision (1429)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2020
Event Type  Injury  
Event Description
A metal trashcan brought into mri suite.The magnetic force pulled it from staffs hand and proceeded to hit mri unit.No patient injury.On (b)(6) 2020, staff member # (b)(6) brought a metal trash can into the mri suite.Based on the ferrous properties of the trashcan, the magnetic force of the mri unit pulled the can from the staffs hand.The trashcan hit the side of the mri unit and did not injure or affect the patient.The staff member did not self report and it was revealed to leadership four days after the event.A full investigation and review of the mri department was performed.All items reviewed for metallic properties and removed or labeled "not mri safe".The staff member was discipline and all members of the mri team at (b)(6) were updated on reporting expectations and their responsibility of the mri safety in their department.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key10483603
MDR Text Key205527366
Report NumberMW5096395
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age41 YR
Patient Weight82
-
-